J&J’s Diabetes Drug Cuts Heart Risk but Amputations Are Hazard

  • Heart attack, stroke, death 14 percent lower with Invokana
  • Higher rate of amputations and fractures could limit use

Johnson & Johnson’s pill Invokana reduced the risk of cardiovascular complications in diabetic patients, making it the second medication of its kind to help the heart, but the benefit came with an increased risk of amputations and perhaps broken bones, researchers said.

Patients given Invokana were 14 percent less likely to suffer a heart attack, stroke or die from heart disease than those given a placebo, according to the combined data from two studies presented at the American Diabetes Association’s annual meeting. The improvement was similar to the results seen with Eli Lilly & Co.’s Jardiance, which was the first diabetes drug shown to protect the heart in 2015.

The findings from the study known as Canvas may boost use of the medicines known as SGLT-2 inhibitors, which make up about 6 percent of the $40 billion spent annually to control diabetics’ blood sugar levels. The rate of amputations seen with Invokana, which doubled compared to the placebo to 6.3 per 1,000 patients treated, and the increase in fractures seen in one of the two studies released on Monday could limit the drug’s use.

The study results are “good for the SGLT-2 class overall, in that it reconfirms the utility of this class of drugs in lowering cardiovascular risk,” said Tim Anderson, an analyst at Sanford C. Bernstein & Co. “But Invokana’s unique amputation risk leaves Jardiance looking better overall.”

Lilly’s shares fell less than 1 percent to $80.63 at 9:48 a.m. in New York. Johnson & Johnson was down less than 1 percent to $131.66.

Amputations, Fractures

Diabetics are already at increased risk for amputations and fractures, and it’s unclear why Invokana seems to exacerbate the situation, said lead investigator Bruce Neal, a professor at the University of New South Wales in Sydney.

“For the great majority of patients with diabetes who are at higher risk of complications, there will be a net benefit,” said Neal. “But there are patients, including those at high risk of amputation, where alternative therapies would be preferred.”

The study that was released at the conference and published in the New England Journal of Medicine also found a decrease in hospitalizations for heart failure and serious declines in kidney function.

Johnson & Johnson, based in New Brunswick, New Jersey, is conducting another trial to determine if Invokana also offers significant protection for the kidneys, said James List, head of cardiovascular and metabolism at the company’s Janssen unit.

Invokana was the first drug of its kind to be approved, in 2013. It works by expelling sugar in the urine after the kidneys have filtered it from the blood. Other drugs in the class include AstraZeneca Plc’s Farxiga and a medication under development by Merck & Co. and Pfizer Inc.

The experience makes doctors more comfortable with the medication, said Tom Donner, director of the Johns Hopkins Diabetes Center in Baltimore. Still, the increased risk of amputations has to be taken into consideration while more data is being gathered on rival medications, he said.

“To date, we have not seen an increase in the amputation signal with the other drugs,” said Donner, who wasn’t involved in the studies. “That does influence your prescribing decision.”

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